NCT06551766

The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy

The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy for the Anastomosis of Lacrimal Cyst Flap and Nasal Mucoperiosteal Flap

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To study the effect of Photosensitive hydrogel used for suture free anastomosis of lacrimal cyst and nasal mucoperiosteal flap in endoscopic nasal dacryocystostomy, and evaluate its adhesion to lacrimal cyst and nasal mucoperiosteal flap, promoting wound healing, forming a good anastomosis, preventing postoperative anastomosis and shortening operation time. Twenty patients with chronic dacryocystitis were randomly divided into photosensitive hydrogel group and suture group.Symptoms and nasal endoscopy were followed up 2, 6, and 12 weeks after surgery for both groups. And also adverse events were recorded at each follow-up.

Detailed description

After endoscopic dacryocystonasal anastomosis, granulation and/or cicatricial adhesion are the main reasons for surgical failure. How to achieve the ideal fit between the lacrimal sac flap and the nasal mucoperiosteal flap and avoid the proliferation of granulation and cicatricial adhesion is very important for the success of the operation. In this study, "photocoupling reaction" technology was used to achieve seamless integration and strong adhesion of photosensitive hydrogel materials to the wound, and the photohydrogel was applied to suture free adhesion and wound repair of the lacrimal cyst mucosal flap and nasal mucosal flap in endoscopic nasal Dacryocystostomy (En-DCR), and its feasibility, safety and effectiveness were evaluated.

Conditions

• Chronic Dacryocystitis

Interventions

Type	Name	Description
DEVICE	Photosensitive hydrogel	In the photosensitive hydrogel group, the anastomosis of the lacrimal cyst mucosal flap and the nasal mucoperiosteal flap was achieved by photosensitive hydrogel.
DEVICE	6-0 absorbable stitches	In the suture fixation group, the anastomosis of the lacrimal cyst mucosal flap and the nasal mucoperiosteal flap was achieved by two stitches using 6-0 absorbable wire.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-08-13
• Last updated: 2024-08-13

Locations

1 site across 1 country: China